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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63488

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 15, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Valeant Pharmaceuticals

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 8

AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.

D-042-2013
Recall number
D-042-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
1,097,846 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled
Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6

Distribution pattern

Nationwide

drug · product 2 of 8

AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3.

D-043-2013
Recall number
D-043-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
477,107 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled
Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3

Distribution pattern

Nationwide

drug · product 3 of 8

AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.

D-044-2013
Recall number
D-044-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
145,650 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled
Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8

Distribution pattern

Nationwide

drug · product 4 of 8

AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.

D-045-2013
Recall number
D-045-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
619,029 tubes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled
Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7

Distribution pattern

Nationwide

drug · product 5 of 8

AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.

D-046-2013
Recall number
D-046-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
71,369 jars

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6

Distribution pattern

Nationwide

drug · product 6 of 8

AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.

D-047-2013
Recall number
D-047-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
81,319 canisters

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled
Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6

Distribution pattern

Nationwide

drug · product 7 of 8

AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.

D-048-2013
Recall number
D-048-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
10,434 canisters

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled
Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9

Distribution pattern

Nationwide

drug · product 8 of 8

AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.

D-049-2013
Recall number
D-049-2013
Initiated
October 15, 2012
Classification
Class III
Status
Terminated
Recalling firm
Valeant Pharmaceuticals
Quantity
115,785 canisters

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled
Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.

Code information

All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2

Distribution pattern

Nationwide